MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

The devices were not made available for evaluation.The root cause is unable to be determined.If any additional information is provided, a supplemental report will be submitted.Journal article citation: frommer, adrien, et al."focal osteolysis and corrosion at the junction of precice stryde.Intramedullary lengthening device." bone and joint research, vol.10, no.7, 16 july 2021.

Event Description

Information was received via literature that newly occurring and persistent limitation of range of motion of the knee or ankle joint after distraction was observed in 4/50 patients.In 2 patients the range of motion was restored by conservative treatment.No additional information was provided.

Manufacturer Narrative

Additional data: b5, h10.

Event Description

Additional information was received via literature review that patients experienced temporary range of motion (rom) limitations in the knee, hip or ankle under distraction and temporary rom in the knee, hip or ankle under consolidation that was resolved by conservative treatment.Conservative treatment is physiotherapy and is expected in limb lengthening treatments.The event has now been deemed not reportable due to the additionally provided information.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 12284954
• MDR Text Key: 265372001
• Report Number: 3006179046-2021-00427
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose